UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053674 |
|---|---|
| Receipt number | R000061231 |
| Scientific Title | A Comparative Study of Skin Status in Individuals with Atopic Dermatitis and Healthy Individuals |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2024/02/21 15:22:52 |
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Basic information
Public title
A Comparative Study of Skin Status in Individuals with Atopic Dermatitis and Healthy Individuals
Acronym
A Comparative Study of Skin Status in Individuals with Atopic Dermatitis and Healthy Individuals
Scientific Title
A Comparative Study of Skin Status in Individuals with Atopic Dermatitis and Healthy Individuals
Scientific Title:Acronym
A Comparative Study of Skin Status in Individuals with Atopic Dermatitis and Healthy Individuals
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic inflammation has occurred in the skin of patients with atopic dermatitis, and various inflammatory cytokines produced during this process are also involved in pigmentation and wrinkle formation, suggesting that they may promote skin aging. This study compares factors and signs of aging associated with atopic dermatitis in healthy individuals to determine the effect of chronic inflammatory symptoms on skin chronological changes.
Basic objectives2
Others
Basic objectives -Others
Survey on actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation between physiological active substance in epidermal horn layer by aging, sex and disease and skin measurement is found.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Males and females aged 18 years or older
2)Those with a diagnosis of atopic dermatitis (atopic dermatitis group) and healthy individuals without skin disease (healthy group).
3)Subjects who have given adequate explanation for participating in the study and who have given written informed consent based on the subject's own free will with adequate understanding.
Key exclusion criteria
1)In the presence of serious skin disease
2)Persons who are pregnant or breastfeeding
3)Other than the above, subjects who are judged by the supervisor to be inappropriate for participation in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsunaka |
Organization
TOKIWA Pharmaceutical Co., Ltd.
Division name
NOV Academic Research
Zip code
1070062
Address
1-2-6 Minami-aoyama Minato-ku
TEL
03-6634-5181
hiroshi_matsunaka@n1.noevir.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Murakami |
Organization
TOKIWA Pharmaceutical Co., Ltd.
Division name
NOV Academic Research
Zip code
1070062
Address
1-2-6 Minami-aoyama Minato-ku
TEL
03-6634-5181
Homepage URL
yumi_murakami@n1.noevir.co.jp
Sponsor or person
Institute
TOKIWA Pharmaceutical Co., Ltd.
Noevir Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOKIWA Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Noevir Co.,Ltd.
Sendai Taihaku Dermatology Clinic, Sendai, Japan.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yoyogi Mental Clinic IRB
Address
4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6804-2227
yumi_murakami@n1.noevir.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
84
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The selection of subjects with atopic dermatitis responds that they have received a diagnosis of atopic dermatitis based on a questionnaire on skin distress in advance, and who wish to participate in this study.
Subjects who are healthy will be selected from those who based on a questionnaire on skin in advance, and who have responded that they are not suffering from skin diseases .
Management information
Registered date
| 2024 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061231
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
